FDA Proposes Additional Information to Better Track Biological Product Deviations

February 1, 2007
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Jan. 30)-The Food and Drug Administration?s Center for Biologics Evaluation and Research (CBER) is proposing an addendum to its current biologics reporting form to better classify potential recalls.

Rockville, MD (Jan. 30)-The US Food and Drug Administration’s (www.fda.gov) Center for Biologics Evaluation and Research (CBER) is proposing an addendum to its current biologics reporting form to better classify potential recalls.

FDA must submit such a request to the Office of Management and Budget (Washington, DC, www.whitehouse.gov/omb) for approval, but first opened up the request for a public comment period of 30 days. Notice of the request was published in the Jan. 30, 2007 issue of the Federal Register (1).

Specifically, CBER is developing an addendum to Form FDA 3486, the form now used to report biological product deviations (BPDs). The Web-based addendum (Form FDA 3486A) would request additional information when a BDP report has been reviewed by FDA and evaluated as a possible recall. The additional information would include information not contained in Form 3486 such as: distribution pattern, method of consignee notification, consignee(s) of products for further manufacture, additional product information, and  updated product disposition.

This information would be requested by CBER through e-mail notification to the submitter of the BDP report and would be used by CBER for the purposes of recall classification.

The new form, Form FDA 3486A, would only be used for biological products regulated by CBER and not biological products regulated by the Center for Drug Evaluation and Research. 

CBER estimates that 5% of the total BDP reports submitted to CBER would need additional information submitted in the addendum. It estimates that it would take between 15 and 45 minutes to complete the addendum. Activities such as investigating, changing standard operating procedures or processes, and follow-up are not included in the calculation of time for the report. 

(1) Reference. US Food and Drug Administration, “Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products; Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A,” Federal Register72 (19), 4267–4269 (Jan. 30, 2007, Docket No. 2006N-0421), http://frwebgate1.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=279262421529+0+0+0&WAISaction=retrieve, accessed Jan. 31, 2007.